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and/or topics in a PA letter. It is being provided to you per your request for suggested language to provide to
Health Plans that have formulary restrictions in place for VASCEPA. This letter is not promotional in nature
but merely provides scientifically accurate and balanced information for your consideration.
I am the prescribing physician for patient {Name}. This patient has triglycerides (TGs) 135-499 mg/dL and
other CV risk factors and requires VASCEPA as the most suitable therapy, based on the available evidence
from clinical trials. For the reasons stated below {tailor points below to the patient specific situation}, in
my medical judgment, other available TG lowering products are not suitable for this patient.
VAS-00734v6 12/18
o In addition, in April 2016, FDA announced the removal of the indication for co-therapy with statin
from all generic Trilipix products. The reason the Agency gave was that “FDA has determined
that the benefits of niacin ER tablets and fenofibric acid DR capsules for coadministration with
statins no longer outweigh the risks, and the approvals for this indication should be withdrawn.”
o Fenofibrate is not indicated or approved for concomitant or adjunctive use with a statin.4
o For the reasons listed above, fenofibrates are not, in my opinion, the most appropriate therapy
for this patient.
VAS-00734v6 12/18
o Organizations such as American Diabetes Association, American Society Health-System
Pharmacists, and American Association of Clinical Endocrinologists, do not recommend omega-3
supplements to treat disease.16,17,18
For the reasons listed above, omega-3 dietary supplements are not, in my medical opinion, the most
appropriate therapy for this patient.
6. Vascepa use in combination with statins is desirable therapy for this patient
o 60% {please update percent to your practice} or greater of my patients are started on a statin to
control their LDL-C levels. When TG levels are at a level studied in REDUCE-IT (135-499 mg/dL), I
want to add Vascepa to help address residual CV event risk beyond cholesterol management.1,2
Please see indication, limitations of use, ISI, additional important information for healthcare professionals, and a
synopsis of the REDUCE-IT study attached. Additionally, going forward, I would recommend that Vascepa be
included in Tier-2 formulary coverage with no restrictions in order to support patient-care options and reduce
the potential need for increased statin dose.
Sincerely,
PHYSICIAN NAME
References:
1 Bhatt DL, Steg PG, Miller M, et al; for the REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia [published
ahead of print.
10 Hilleman D, Smer A. Prescription omega-3 fatty acid products and dietary supplements are not interchangeable. Manag Care. 2016;25(1):46-52.
11 Davidson MH. Omega-3 fatty acids: new insights into the pharmacology and biology of docosahexaenoic acid, docosapentaenoic acid, and
for Management of Dyslipidemia and Prevention of Atherosclerosis. Endocr Pract. In press. doi:10.4158/EP171764.GL.
19 NIASPAN [package insert]. North Chicago, IL: AbbVie; 2015